Pharma Phriday (April 3, 2026)

Written by Duncan Emerton, Pharma Phriday is a comprehensive weekly update on the pharmaceutical industry, covering clinical trial results, regulatory approvals, corporate development activity, and other significant developments.

In this week’s note:

Clinical

• Alkermes initiates Phase III trials for alixorexton in NT1 and NT2

• AstraZeneca’s efzimfotase alfa misses Phase III trial goal

• AstraZeneca's tozorakimab meets Phase III COPD trial goal

• Biogen announces positive Phase II data for litifilimab in CLE

• Connect posts positive Phase III data for rademikibart

• Merck & Co. posts positive Phase III results for oral PCSK9 inhibitor, enlicitide

• Novocure reports positive Phase II data for its TTFields therapy

• Prilenia and Ferrer recruit first patient for the Phase III PREVAiLS study

• Takeda’s zasocitinib delivers in Phase III psoriasis study

• Wave Life Sciences reports six month Phase I data for WVE-007

Regulatory

• EMA accepts GSK’s bepirovirsen MAA for regulatory review

• FDA approves Eli Lilly’s oral GLP-1 agonist, Foundayo (orforglipron)

• FDA approves Novo Nordisk’s once-weekly Awiqli

• J&J’s Darzalex subQ gets CHMP nod for multiple myeloma

• Sanofi’s Sarclisa subQ on-body injector gets CHMP nod for multiple myeloma

• Second times a charm for Corcept’s Lifyorli

• Teva shares three positive biosimilar regulatory updates

Commercial

• Biogen to acquire Apellis for $5.6 billion

• Eli Lilly and Insilico Medicine strike deal for AI-developed drugs

• Eli Lilly to acquire Centessa Pharmaceuticals for $6.3 billion upfront

• Infinimmune buddies up with Merck & Co. on antibody R&D

• Novartis to acquire Excellergy for $2 billion

• Otsuka to acquire Transcend Therapeutics for $1.2 billion

• Tempus partners with Daiichi Sankyo on AI-driven R&D

In Brief

• Biogen’s high dose Spinraza gets FDA nod

• Ebglyss shows durable efficacy in eczema

• Eisai/Nuvation Bio’s taletrectinib MAA validated by EMA

• Eli Lilly pushes UK on pricing in exchange for investment

• EMA softens biosimilar development requirements

• GSK’s Exdensur (depemokimab) approved in China

• Kardigan’s tonlamarsen shows promise in hypertension

• Kodiak’s Zenkuda succeeds in Phase III

• Neion Bio enters biosimilar manufacturing

• CVC bids €10.9 billion for Recordati

• Rocket secures gene therapy approval plus PRV upside

• Simulations Plus expands AI collaborations

• UCB’s Kygevvi approved in Europe

• Viridian’s elegrobart succeeds in Phase III

Clinical

Alkermes initiates Phase III trials for alixorexton in NT1 and NT2

What happened. Alkermes has announced the initiation of the Phase III BRILLIANCE programme, a collection of studies which will evaluates the safety and efficacy of alixorexton compared to placebo in adults with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). Alixorexton is the company’s novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of NT1, NT2 and idiopathic hypersomnia (IH). The BRILLIANCE programme consists of three 12-week, randomised, double-blind, placebo-controlled Phase III studies evaluating once-daily and split-dose regimens of alixorexton: BRILLIANCE NT1 (Study 302 and Study 304) and BRILLIANCE NT2 (Study 303). The primary endpoint of each study will assess whether participants taking alixorexton experience an increase in wakefulness compared to participants taking placebo, as measured by the change in mean sleep latency on the maintenance of wakefulness test (MWT). Alixorexton is also being assessed in the Phase II VIBRANCE-3 study in patients with idiopathic hypersomnia (IH).

Why this matters. The initiation of the Phase III BRILLIANCE programme comes as no surprise considering alixorexton’s solid performance in the Phase II VIBRANCE-1 study where alixorexton met its primary endpoint across all tested doses, and the subsequent FDA Breakthrough Therapy designation for narcolepsy type 1. The competitive context is significant. Takeda's oveporexton (TAK-861), a closely related OX2R agonist, already has an FDA NDA under Priority Review with a PDUFA target date in Q3 2026, meaning Takeda is likely to be first to market in this class. Alkermes is therefore entering Phase III as a second mover in the orexin agonist space, and its commercial case will depend on demonstrating differentiated efficacy or tolerability data rather than novelty alone. On balance, this is an important clinical advance for Alkermes, though alixorexton’s ultimate commercial value will be shaped by how it performs head-to-head with an anticipated competitor that is substantially further along the regulatory path.

AstraZeneca’s efzimfotase alfa misses Phase III trial goal

What happened. AstraZeneca has shared results from three Phase III trials of efzimfotase alfa, its investigational enzyme replacement therapy for hypophosphatasia (HPP) patients aged ≥2 years, including those without bone symptoms. Efzimfotase alfa is being developed as a subQ treatment administered every two weeks to replace the deficient alkaline phosphatase (ALP) enzyme activity that is the underlying cause of HPP. Both the MULBERRY (placebo-controlled, paediatric) and CHESTNUT (open-label maintenance, paediatric patients, previously treated with Strensiq) trials achieved statistical significance, but the HICKORY trial (placebo-controlled, adolescents and adults) showed only numerical improvements. Efzimfotase alfa was well-tolerated and had an acceptable safety profile across all three trials.

Why this matters. This data shows clear efficacy in paediatric patients but mixed outcomes in adolescents and adults, where the primary endpoint was not met. This supports lifecycle expansion of its rare disease franchise and strengthens the paediatric standard while leaving room for others in adult populations. Patients may benefit from improved outcomes and reduced treatment burden, though uncertainty remains beyond paediatrics. The potential stumbling block is regulator and payer scrutiny tied to the adult data. Overall, success is evident, but label breadth will determine the true commercial impact.

AstraZeneca's tozorakimab meets Phase III COPD trial goal

What happened. AstraZeneca has announced positive high-level results from the Phase III OBERON and TITANIA trials in patients with chronic obstructive pulmonary disease (COPD). Data show that tozorakimab (anti-IL-33) reduced the annualised rate of moderate-to-severe COPD exacerbations compared with placebo, in the primary population of former smokers, and in the overall population, which included former and current smokers, and patients across all blood eosinophil counts and all stages of lung function severity. Tozorakimab was generally well tolerated with a favourable safety profile. According to AZ’s PR, tozorakimab uniquely inhibits the signalling of the reduced and oxidised forms of IL-33, offering the potential to both reduce inflammation and disrupt the cycle of mucus dysfunction that contribute to COPD worsening. In the OBERON and TITANIA trials, tozorakimab was studied in patients with COPD still experiencing exacerbations while on inhaled standard of care. Patients received tozorakimab 300mg or placebo on top of standard of care once every four weeks. Additional Phase III trials of tozorakimab in COPD (PROSPERO and MIRANDA) are ongoing.

Why this matters. This is a highly significant result considering other anti-IL-33 mAbs (e.g., itepekimab from Sanofi/Regeneron, and Roche’s astegolimab) have failed to demonstrate consistent benefit in patients with COPD. Importantly, tozorakimab significantly reduced the moderate-severe exacerbation rate in both the primary population of former smokers but also in the overall COPD population, and across all blood eosinophil counts. This marks a notable milestone in the IL-33/COPD hypothesis given limited conviction in the mechanism following prior failures. Analysts from Jefferies note that their discussions with AZ suggest both Phase III trials, OBERON and TITANIA, were independently successful. They also note that because tozorakimab works in all comers and across all blood eosinophil counts, tozorakimab could more than double the eligible biologics population, while also potentially competing with Dupixent (dupilumab) in the overlapping type 2 segment, if competitive.

Biogen announces positive Phase II data for litifilimab in CLE

What happened. Biogen has announced positive results from the Phase II part of the AMETHYST Phase II/III study (Part A) of litifilimab in patients with cutaneous lupus erythematosus (CLE). Litifilimab is the first humanized anti-IgG1 targeting blood dendritic cell antigen 2 (BDCA2), which has the potential to become the first therapy approved for CLE in 70 years. Part A of AMETHYST evaluated the efficacy and safety of litifilimab through week 24, with reductions in skin disease activity reported across several measures. Results are consistent with the earlier positive Phase II LILAC study. Data from LILAC and AMETHYST supported litifilimab being granted FDA Breakthrough Therapy Designation in January 2026. AMETHYST Part A met its primary endpoint with litifilimab demonstrating a statistically significant 11.8% higher reduction in disease activity in people living with CLE at Week 16, compared to placebo. Litifilimab was generally well tolerated in Part A of the AMETHYST study and tolerability was consistent with the LILAC study.

Why this matters. For Biogen, a second positive Phase II study strengthens confidence that litifilimab can become the first targeted therapy for CLE, and supports the ongoing Phase III AMETHYST programme, with readout expected in 2027. In AMETHYST Part A, 14.7% of litifilimab-treated patients achieved clear or almost clear skin at week 16 versus 2.9% on placebo. For competitors, this sharpens pressure in lupus, although Benlysta and Saphnelo are approved for SLE, not CLE. For patients, the significance is clear because CLE can scar and disfigure, and no targeted treatments are approved. The main caveat is that Phase III confirmation is still needed.

Connect posts positive Phase III data for rademikibart

What happened. Connect Biopharma has announced results from the Phase III RADIANT-AD study of rademikibart in Chinese patients with moderate‑to‑severe atopic dermatitis (AD). Rademikibart is a human IL-4Rα mAb designed to treat Th2-related inflammatory diseases, such as moderate-to-severe asthma and atopic dermatitis, by blocking IL-4 and IL-13 signalling. The study was conducted by Connect’s partner in China, Simcere Pharmaceutical. The study enrolled n=259 adolescent and adult patients with moderate‑to‑severe AD, who were randomised to receive rademikibart 300mg administered every two weeks or placebo via subQ injection during a 16‑week induction phase. This was followed by a 36-week maintenance phase in which patients randomised to rademikibart continued rademikibart and patients randomized to placebo switched to rademikibart. At Week 52, rademikibart demonstrated strong maintenance of response among Week 16 responders, with continued improvement across all key efficacy endpoints (i.e., EASI-75, IGA 0/1 and EASI-90). Rademikibart was well tolerated with placebo-like safety at 16 weeks and lower rates of conjunctivitis than other agents in the class (e.g., dupilumab).

Why this matters. These Phase III data give rademikibart real strategic value by showing strong efficacy and favourable safety in atopic dermatitis, with Simcere already advancing a China NDA. At week 16, rademikibart beat placebo on key endpoints including IGA 0/1, EASI-75, EASI-90 and itch reduction, with responses improving further through week 52. That raises the competitive bar in a market where Dupixent, Adbry and Ebglyss are already approved. For patients, the attraction is rapid itch relief, deeper skin clearance and a low conjunctivitis rate. The main caveat is that this was a China partner study, and cross-trial superiority claims still need caution. Overall, this is credible differentiation with lifecycle value.

Merck posts positive Phase III results for oral PCSK9 inhibitor, enlicitide

What happened. Merck & Co. has announced detailed results from CORALreef AddOn, an active comparator study designed to evaluate the efficacy and safety of enlicitide decanoate compared to other oral non-statin therapies (bempedoic acid, ezetimibe or bempedoic acid with ezetimibe) when added to background statins in adults with hypercholesterolemia who have a history of or are at risk for atherosclerotic cardiovascular disease (ASCVD). In the study, treatment with enlicitide resulted in statistically significant and clinically meaningful reductions in LDL-C compared to bempedoic acid, ezetimibe or bempedoic acid with ezetimibe at eight weeks of treatment. The observed LDL-C reduction resulted in greater LDL-C goal attainment with enlicitide than the comparators (secondary endpoint). Results from CORALreef AddOn showed that at eight weeks, enlicitide reduced LDL-C by 64.6% from baseline when added to background treatment with a statin. Additionally, enlicitide reduced LDL-C by 56.7% versus bempedoic acid, 36.0% versus ezetimibe and 28.1% versus bempedoic acid with ezetimibe. The overall safety profile was consistent with that observed in the Phase 3 CORALreef Lipids and CORALreef HeFH clinical trials. High adherence with study intervention (98%) and dosing instructions (≥96%) were observed across treatment groups. In December 2025, the FDA selected enlicitide to receive the Commissioner’s National Priority Voucher (CNPV).

Why this matters. This data from CORALreef AddOn strengthens the case that enlicitide could become the first approved oral PCSK9 inhibitor and a potentially important cardiovascular growth asset for Merck & Co. In this Phase III study, enlicitide delivered greater LDL-C lowering than bempedoic acid, ezetimibe, or their combination when added to statins. That matters competitively because Merck & Co. is not only challenging today’s oral non-statin therapies but also building a future oral alternative in a market currently led by injectable PCSK9 agents and inclisiran. This will also appeal to patients, as they will be able to benefit from potent LDL-C reduction in a once-daily pill, High adherence in the trial suggests a very clean tolerability profile. The main caveat is that these are short-term lipid data, so long-term outcomes, real-world adherence, and practical issues such as fasting dosing will still matter. Overall, this looks like one of Merck & Co.’s more commercially credible pipeline assets.

Novocure reports positive Phase II data for its TTFields therapy

What happened. Novocure has announced positive results today from the Phase II PANOVA-4 trial of Tumour Treating Fields (TTFields) therapy concomitant with atezolizumab (Tecentriq; Roche), gemcitabine and nab-paclitaxel (gem/nab-pac) as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC). PANOVA-4 met its pre-specified primary endpoint, achieving a statistically significant improvement in disease control rate (DCR) compared to the DCR reported in the Phase III MPACT study used as the historical control. The DCR in patients treated with TTFields therapy concomitantly with atezolizumab and gem/nab-pac (N=78) was 74.4% compared to a DCR of 48% in patients receiving gem/nab-pac alone (N=431) in the historical control (difference = 26.4%, 1-sided p-value < 0.001). In the PANOVA-4 trial, DCR was defined as the proportion of patients who had either stable disease (SD) for at least 16 weeks or confirmed partial response (PR) or complete response (CR) according to the Response Evaluation Criteria in Solid Tumours (RECIST v1.1).

Why this matters. This data in 1L treatment of pancreatic cancer comes after Novocure secured FDA approval for Optune Pax as a treatment for locally advanced (non-metastatic) pancreatic cancer in combination with gem/nab-pac in February 2026. Approvals have also been obtained in newly diagnosed GBM, malignant pleural mesothelioma and metastatic NSCLC. TTFields are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. Novocure’s intention with this data is to expand TTFields into earlier-stage and metastatic pancreatic cancer, thereby increasing the treatment’s accessible market.

Prilenia and Ferrer recruit first patient for the Phase III PREVAiLS study

What happened. Prilenia Therapeutics and Ferrer have announced the first enrollment in the pivotal Phase III PREVAiLS study which will assess the efficacy of pridopidine in people with rapidly progressive amyotrophic lateral sclerosis (ALS) early in their disease course. Pridopidine is a sigma-1 receptor (S1R) agonist, with S1R having been shown to play a role in stimulating multiple neuroprotective pathways impaired in neurodegenerative diseases, such as ALS and Huntington’s disease. PREVAiLS is informed by peer-reviewed and published data from a subgroup analysis of similar participants with rapidly progressive ALS early in their disease course from the Phase II HEALEY ALS Platform Trial. The HEALEY trial did not meet its primary or secondary endpoints in the full population, but pre-specified and additional analyses showed effects in rapid progressive patients that the PREVAiLS study hopes to confirm. Recall, Prilenia Therapeutics and entered into a collaboration and license agreement with Ferrer for the commercialisation and further development of pridopidine in Europe and other select markets in April 2025.

Why this matters. To be transparent, I have a deep interest in ALS. Although clinical breakthroughs have been difficult to achieve, the significant unmet need in this area motivates me to highlight company investments and trial announcements whenever possible. Enrolling the first participant in PREVAiLS marks a critical milestone for pridopidine in rapidly progressive ALS. The Phase III study is designed to validate subgroup signals seen in the Phase II HEALEY ALS platform trial, where overall endpoints were missed but potential benefit emerged in early, fast‑progressing patients. If successful, this would differentiate pridopidine in a field with limited disease‑modifying options, rather than directly displacing existing ALS therapies. For patients, the focus on early intervention offers the prospect of slowing functional decline in a setting of high unmet need. The key caveat is reliance on subgroup-driven Phase II data, which raises execution and regulatory risk. Overall, PREVAiLS is a high‑risk but clinically meaningful bet in ALS. I wish Prilenia and Ferrer every success with this trial and will be monitoring developments closely.

Takeda’s zasocitinib delivers in Phase III psoriasis study

What happened. Takeda has announced new data from the two pivotal Phase III studies (Latitude PsO 3001 and 3002) of zasocitinib, a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis. In the trials, improvement was observed as early as week 4 and symptoms continued to moderate over time. At week 16, 57% of patients treated with zasocitinib had achieved PASI 90 versus 5% in the placebo group and 17% in the apremilast (Otezla) group, while 29% (versus 1% and 4%) had achieved PASI 100, which indicates clear skin. Improvement was even greater at week 24. In terms of safety profile, the incidence of serious treatment-emergent adverse events (TEAEs) was 3.2%, slightly higher than for Otezla and for J&J’s Icotyde (icotrokinra; anti-IL-23). The most common TEAEs for zasocitinib-treated patients were upper respiratory tract infection and acne. In its PR Takeda said that the adverse events were manageable, and that other adverse events occurred less frequently than with Otezla. Takeda also said that while there had been one death, this had taken place a day after the first dose and had no causal relationship with the drug.

Why this matters. This data positions zasocitinib as a credible growth asset that could form a critical part of Takeda’s inflammation portfolio, showing high rates of skin clearance. Zasocitinib clearly outperformed apremilast, which raises the competitive bar for oral therapies and increases pressure on Bristol Myers Squibb’s Sotyktu and emerging TYK2 programmes. With the caveat that cross-trial comparisons can be unreliable, zasocitinib appears to have an advantage over Sotyktu. BMS reported PASI 90 rates of 32% to 42% and PASI 100 rates of 10% to 14% in its Phase III programme. For patients, the prospect is biologic‑like efficacy in a pill, with rapid onset and durable responses. The main caveats are longer‑term safety monitoring and how regulators and payers view oral immunomodulators in a crowded market. Overall, this strengthens Takeda’s case for a differentiated oral option in psoriasis.

Wave Life Sciences reports six month Phase I data for WVE-007

What happened. RNA medicines developer, Wave Life Sciences, has announced new data from the Phase I portion of its first-in-human INLIGHT trial evaluating WVE-007 (INHBE GalNAc-siRNA) in otherwise healthy individuals living who are overweight or obese. After six months of follow-up, a single 240mg dose led to further improvements in body composition, including fat loss with muscle preservation, with clinically meaningful reductions in visceral fat and waist circumference in a population with less fat and lower BMI than those in reference Phase II and III obesity studies. WVE-007 works by silencing Inhibin Subunit Beta E (INHBE) and its downstream gene product, Activin E, which induces fat loss through lipolysis, the breakdown of triglycerides directly in adipocytes, without reducing muscle. Placebo-adjusted weight loss in the 32-subject Phase I trial cohort was 0.9% after six months, versus 0.3% after three months. WVE-007 continues to be generally safe and well tolerated. There were no treatment discontinuations, and no severe or serious treatment emergent adverse events (TEAEs). 

Why this matters. This data raises some interesting (perhaps philosophical) questions regarding the best outcome for the pharmacological treatment of obesity. Is it better to lose weight (which on GLP-1s includes fat and muscle) or is it better to focus on body composition? While a single dose of WVE-007 failed to move the needle on body weight, it did deliver a placebo-adjusted 14% reduction in visceral fat and preservation of lean mass at six months. Recall, elevated levels of visceral fat (i.e., fat stored deep around your organs, not just under the skin) is associated with an increase risk of CVD, diabetes, neurological decline and cancer. If confirmed, this could complement rather than directly displace GLP‑1 drugs, which dominate the market but are associated with muscle loss and frequent dosing. Wave expects to initiate new clinical trials evaluating WVE-007 as an add-on to GLP-1s and as post-incretin maintenance in 2026. One would hope that the outcome from these trials is like what Eli Lilly reported for bimagrumab (anti-activin type II receptor mAb) which helped patients lose weight and preserve muscle mass when used in combination with semaglutide.

Regulatory

EMA accepts GSK’s bepirovirsen MAA for regulatory review

What happened. GSK has announced that the EMA has accepted for review the marketing authorisation application (MAA) for the use of bepirovirsen, an investigational antisense oligonucleotide (ASO), in the treatment of adults with chronic hepatitis B (CHB). The regulatory submission to EMA is based on positive results from the Phase III B-Well 1 and B-Well 2 trials. Both trials met their primary endpoint, and bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. Functional cure rates were significantly higher with bepirovirsen plus standard of care compared with standard of care alone. Results were statistically significant across all ranked endpoints, including in patients with baseline surface antigen (HBsAg) ≤1000 IU/ml where an even greater effect was demonstrated. The trials demonstrated an acceptable safety and tolerability profile consistent with what was reported in other studies.

Why this matters. The EMA’s acceptance of GSK’s MAA comes a couple of months after GSK and its partner, Ionis Pharmaceuticals, announced topline results from B-Well 1. For patients living with hepatitis B, approval won’t come soon enough. Current treatment focuses on controlling the virus to prevent liver damage rather than a complete cure, typically involving daily oral antiviral medicines or interferon injections. Bepirovirsen is considered a potential first-in-class treatment rather than a "me-too" approach because it introduces a novel mechanism of action aimed at a functional cure, something current standard-of-care treatments rarely achieve. Current treatments like entecavir and tenofovir are nucleos(t)ide analogues (NAs) that suppress the virus but typically require lifelong use. Bepirovirsen is designed as a finite therapy (e.g., 24 weeks) with the goal of achieving a functional cure (i.e., sustained undetectable virus levels after stopping all medication).

FDA approves Eli Lilly’s oral GLP-1 agonist, Foundayo (orforglipron)

What happened. Eli Lilly has announced that the FDA has approved Foundayo (orforglipron), its once-daily small molecule (non-peptide) oral GLP-1 receptor agonist, for adults who are overweight or who are obese. Foundayo is expected to be shipped and made available to patients on April 6, 2026. Approval was based on data from the ATTAIN clinical trial programme which showed that, orforglipron was proven to help people lose weight and keep it off. In the ATTAIN-1 trial (i.e., obesity/overweight without type 2 diabetes), individuals taking the highest dose of orforglipron and who stayed on treatment lost an average of 12.4% of body weight, compared to 0.9% with placebo. Participants taking orforglipron, regardless of trial completion, lost an average of 11.1% of body weight, compared to 2.1% with placebo. In the ATTAIN programme, orforglipron also led to reductions in many markers of cardiovascular risk, including waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure across all doses. Unlike other GLP-1s, orforglipron can be taken any time of the day without restrictions on food and water intake. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnoea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.

Why this matters. Lilly’s 2018 bet, when it licensed rights to orforglipron (formerly OWL833) from Chugai, has paid off. While Lilly’s other products deliver greater body weight reductions (e.g., tirzepatide delivered ~16% weight loss in SURMOUNT-2), orforglipron allows Lilly to compete with Novo Nordisk’s oral version of Wegovy (semaglutide), approved by the FDA in December 2025, and flip the script on weight management. This is the first GLP-1 that genuinely behaves like a primary care drug, not a specialist product because there are no food/water restrictions. In terms of the data, there was no mention of results from the ATTAIN-2 trial in the PR, which might concern some folks. While data from the ATTAIN-2 were positive, reductions in body weight were not as great as compared to ATTAIN-1 (e.g., patients taking the highest dose of orforglipron lost 9.6% of body weight). Lower weight loss in ATTAIN-2 (diabetic population) versus ATTAIN-1 aligns with well-established GLP-1 class effects, where metabolic constraints and concomitant therapies in diabetic patients reduces absolute weight reduction. Overall, the approval of orforglipron marks the transition of GLP-1s from high-efficacy specialty injectables to scalable, primary-care-friendly oral therapies, which is likely to expand the obesity market rather than merely intensifying competition. As Reuters opined in its coverage, oral weight-loss drugs are not expected to ​fully replace injectables, which can deliver greater ​weight loss, but analysts estimate pills ⁠could capture around 20% of the market by 2030.

FDA approves Novo Nordisk’s once-weekly Awiqli

What happened. Novo Nordisk has announced that the FDA has approved Awiqli (insulin icodec; 700 units/mL), a once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycaemic control in adults living with type 2 diabetes. The approval is based on results from the Phase III ONWARDS programme, which comprised four randomised, active-controlled, treat-to-target trials in approximately 2,680 adults with uncontrolled type 2 diabetes, used in combination with a mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1 receptor agonists. The clinical programme evaluated once-weekly Awiqli vs daily basal insulin (insulin glargine) and demonstrated efficacy in the primary endpoint of HbA1c reduction across the ONWARDS pivotal clinical trial programme in adults with type 2 diabetes. Across ONWARDS trials, the safety profile of Awiqli was overall consistent with the daily basal insulin class.

Why this matters. The FDA approval of Awiqli is significant as it will transforming the treatment paradigm from 365 to 52 injections per year, directly addressing common barriers like injection fatigue and non-adherence. By reducing injections from daily to weekly, Awiqli simplifies daily routines and Novo Nordisk will hope that this encourages earlier adoption of insulin therapy for patients who have previously delayed it. To support this, Awiqli will need to be competitively priced vs. other branded and biosimilar basal insulins.

J&J’s Darzalex subQ gets CHMP nod for multiple myeloma

What happened. Johnson & Johnson has announced that the EMA’s CHMP has granted approval for a Type II variation to the labelling for Darzalex (daratumumab) subQ formulation. The label update enables patients living with multiple myeloma or their caregivers to administer daratumumab from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training.

Why this matters. This Type II variation officially allows Darzalex subQ to be self-administered by patients or their caregivers starting from the fifth dose. This makes it the first oncology injectable in Europe approved for use in an at-home setting. Patients can now choose, together with their doctors, whether to receive treatment in a clinic or at home, offering greater control over their daily lives. Importantly, the update applies to all ten therapeutic indications of Darzalex subQ, covering various stages of multiple myeloma, smouldering multiple myeloma, and light chain (AL) amyloidosis. For J&J, this update provides a significant competitive advantage over other MM therapies that still require professional administration in a hospital or clinic setting. It also helps protect the drug's market position as IV patents expire.

Sanofi’s Sarclisa subQ on-body injector gets CHMP nod for multiple myeloma

What happened. The EMA’s CHMP has adopted a positive opinion recommending the approval of Sarclisa (isatuximab) subQ in combination with approved standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all currently approved indications for Sarclisa intravenous (IV) formulation in the EU. If approved, Sarclisa would be the first available anticancer treatment to be administered through both an on-body injector (OBI) and manual injection, and the only anti-CD38 mAb available in MM to offer the flexibility of both an OBI and manual injection. A final EC approval is expected in 60 days. The positive CHMP opinion is based on the results from the Phase III IRAKLIA study R/RMM which demonstrated non‑inferiority of the subQ formulation compared to the IV formulation. Four other studies supported the decision; GMMG-HD8, IZALCO, ISASOCUT and a Phase I study.

Why this matters. The EMA’s CHMP positive opinion potentially makes Sarclisa the first anticancer treatment in the EU available via an on-body injector (OBI). Recall, Neulasta and certain biosimilars of pegfilgrastim can be delivered by OBI, these products are used in supportive care and do not treat the underlying cancer. And in contrast to the news from J&J regarding its Type II variation for Darzalex (see previous section), the Sarclisa recommendation focuses on providing a dual delivery system: patients can receive it either through a manual subcutaneous injection or a wearable on-body injector, but the current recommendation for Sarclisa subQ focuses on administration flexibility within a clinical setting or by a healthcare professional, and not at home.

Second times a charm for Corcept’s Lifyorli

What happened. Only a few months after the FDA rejected Lifyorli (relacorilant) for the treatment of Cushing’s related hypertension, Corcept Therapeutics has announced that the FDA has approved it first-in-class selective glucocorticoid receptor antagonist (SGRA), Lifyorli (relacorilant), in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Eligible patients must have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. Approval was based on the positive outcomes of the Phase III ROSELLA trial, which enrolled 381 patients with platinum-resistant ovarian cancer. Patients were randomized 1:1 to receive either Lifyorli plus nab-paclitaxel or nab-paclitaxel monotherapy. No biomarker selection was required. ROSELLA met its dual primary endpoints of progression-free and overall survival. The combination of Lifyorli with nab-paclitaxel was well-tolerated and manageable.

Why this matters. This approval introduces the first and only SGRA for cancer, as it addresses a critical treatment gap for patients with platinum-resistant ovarian cancer who have few effective options after initial therapies fail. The ROSELLA trial demonstrated that adding Lifyorli to nab-paclitaxel significantly improved overall survival compared to chemotherapy alone, and the combination reduced the risk of disease progression by 30%. While oncologists have opined that Lifyorli is positioned to become a new standard-of-care for this difficult-to-treat patient population, price could be a factor in its uptake. Corcept Therapeutics has set the wholesale price at $37,900 for a four-week cycle (equating to ~$450,000 per year).

Teva shares three positive biosimilar regulatory updates

What happened. Teva has announced three milestones in its biosimilar portfolio. First up, the FDA has approved Ponlimsi (denosumab) as a biosimilar to Prolia, and Teva’s applications for a proposed biosimilar candidate to Xolair (omalizumab) have been accepted by both the FDA and EMA. The FDA approval of Ponlimsi was based on a totality of evidence, including analytical and clinical data demonstrating similar efficacy, safety, and immunogenicity profile as the reference product, Prolia. Ponlimsi is approved for all indications of the reference product Prolia. Ponlimsi was approved by the EMA in November 2025. The regulatory submissions for the biosimilar candidate to Xolair (omalizumab) (BLA in the US and MAA in Europe) include all FDA and EMA approved indications for Xolair.

Why this matters. Teva has expanded its "pivot to growth" strategy with the FDA approval of Ponlimsi (denosumab) for osteoporosis and the filing acceptance for a Xolair (omalizumab) biosimilar in Europe and the US, driving competition against Amgen, Novartis, and Roche, and other biosimilar developers. Ponlimsi enters the market against biosimilar denosumab competitors including Sandoz and Celltrion, while the Xolair candidate will face rivalry from Celltrion's approved interchangeable biosimilar, Omlyclo, which was approved in March 2025.

Commercial

Biogen to acquire Apellis for $5.6 billion

What happened. Biogen and Apellis Pharmaceuticals have announced a definitive agreement under which Biogen has agreed to acquire Apellis $5.6 billion. The addition of Apellis adds two commercialised immunology and rare disease medicines to its portfolio: Empaveli (PNH and C3G) and Syfovre (GA in AMD). Both add immediate sales revenue to Biogen, having achieved combined net sales of $689 million in 2025. Both products contain the same active ingredient, pegcetacoplan, which is a complement C3 inhibitors that work by blocking C3 and downregulating the complement system. Biogen believes that Apellis’ established US sales infrastructure in nephrology will support the roll out of felzartamab, which is currently in Phase III studies for three kidney diseases with the first trial readout expected in the first half of 2027. Biogen will continue to work with Sobi, which retains commercial rights to Aspaveli in the EU.

Why this matters. Biogen’s acquisition of Apellis is a calculated move to add near‑term revenue and reduce reliance on a maturing neurology franchise (e.g., Tecfidera, Vumerity, Tysabri and interferon-based therapies). It also strengthens Biogen’s position in immunology and nephrology, increasing pressure on rivals active in complement biology. The only potential wrinkle is the ongoing debate around Syfovre’s benefit–risk profile (i.e., modest efficacy, rare but serious risks, and the practicalities of administration) and how it compares to other treatments for GA in AMD. While Syfovre is not clearly inferior on efficacy alone, other treatments (e.g., Izervay) are often perceived as safer, which shapes how Syfovre is judged in real‑world practice. Overall, this is a pragmatic growth acquisition that broadens Biogen’s therapeutic footprint.

Eli Lilly and Insilico Medicine strike deal for AI-developed drugs

What happened. Insilico Medicine has announced a drug discovery collaboration with Eli Lilly that uses Insilico’s AI engine to accelerate the discovery and development of novel therapeutics across multiple therapeutic areas. The agreement grants Lilly an exclusive worldwide license for the development, manufacturing, and commercialisation of novel oral therapeutics in preclinical development for certain indications. In addition, Insilico and Lilly will collaborate on multiple R&D programs focused on targets selected by Lilly, by combining Insilico’s state-of-the-art Pharma.AI platforms with Lilly’s development capabilities and deep disease-area expertise. Under the terms of the agreement, Insilico is eligible to receive a $115 million upfront payment, followed by development, regulatory, and commercial milestones that could bring the total deal value to approximately $2.75 billion, plus tiered royalties on future sales.

Why this matters. Eli Lilly continues to go all in on AI-driven drug discovery having secured a number of AI-focused collaborations since the beginning of 2025, including deals with NVIDIA, Nimbus Therapeutics and BigHat Biosciences. And like Eli Lilly, big pharma peers are also getting in on the act, with companies such as AstraZeneca (CSPC Pharmaceuticals, Modella AI), Novartis (Relation Therapeutics, Unnatural Products) and Sanofi (Earendil Labs, Formation Bio) all leading the AI charge. For additional insight into other AI/pharma deals, click here. From Insilico’s perspective, this move strengthens the company’s positioning against other AI‑native drug discovery firms by signalling operational depth and readiness for large pharma collaborations.

Eli Lilly to acquire Centessa Pharmaceuticals for $6.3 billion upfront

What happened. Eli Lilly and Centessa Pharmaceuticals have announced a definitive agreement for Lilly to acquire Centessa. Centessa is advancing a pipeline of orexin receptor 2 (OX2R) agonists designed to excessive daytime sleepiness and disorders of impaired wakefulness. Its lead investigational candidate cleminorexton (formerly ORX750) has demonstrated a potential best-in-class profile in Phase IIa clinical studies across narcolepsy type 1 and type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Under the terms of the transaction Lilly will pay $7.8 billion for Centessa, which includes upfront cash of $6.3 billion and an additional potential aggregate equity value of approximately $1.5 billion.

Why this matters. Eli Lilly continues to invest in M&A as it seeks to gain access to new therapy areas and platform technologies. Other acquisitions include Orna Therapeutics (cell therapies), Ventyx Biosciences (inflammatory diseases) and Adverum Biotechnologies (ophthalmology). With no overlap with currently approved products or pipeline programmes, the acquisition of Centessa give Eli Lilly the opportunity to compete in the narcolepsy market alongside Jazz Pharma, Takeda (oveporexton), Alkermes (via its October 2025 acquisition of Avadel) and Eisai. Key caveats for all of Eli Lilly’s acquisitions include remaining clinical risk, regulatory hurdles, and the integration of pipeline programmes. Overall, the acquisition reflects Lilly’s willingness to deploy capital to build long‑term neuroscience growth.

Infinimmune buddies up with Merck & Co. on antibody R&D

What happened. Infinimmune has announced a collaboration with Merck & Co. to apply Infinimmune’s human-first antibody discovery platform to identify and develop antibody candidates against multiple undisclosed targets designated by Merck & Co. Under the agreement, Infinimmune will use its proprietary Anthrobody discovery platform and GLIMPSE antibody language model to discover and optimize therapeutic antibodies derived directly from human immune repertoires. Merck & Co. will have the exclusive right to develop and commercialise antibody candidates arising from the collaboration. Under the terms of the agreement, Infinimmune will receive an undisclosed upfront payment and is eligible to receive milestone payments associated with the progress of multiple antibody candidates all totaling up to approximately $838 million.

Why this matters. Partnering with Merck validates Infinimmune’s AI‑enabled antibody discovery platform and provides an injection of capital which secures the company’s growth aspirations. In addition to prospecting for antibodies on behalf of Merck & Co., Infinimmune is also advancing its own preclinical pipeline. Launched in 2022 with $12 million seed financing, the biotech has a portfolio that is headed up by an interleukin-22-targeting antibody currently in development for atopic dermatitis. For Merck & Co. the deal provides another source of early‑stage innovation as it seeks to diversify beyond established franchises. Overall, this is a platform‑validation collaboration rather than a near‑term product story.

Novartis to acquire Excellergy for $2 billion

What happened. Novartis has announced that it has entered into an agreement to acquire Excellergy, a private biotech company developing next-generation anti-IgE therapies for IgE-driven diseases. The proposed acquisition adds EXL-111, a half-life extended, high-affinity anti-IgE antibody currently in Phase I trials. Under the terms of the agreement, Novartis will pay up to $2 billion in upfront and milestone payments to acquire Excellergy. The transaction is expected to close in H2’26, subject to the satisfaction or waiver of customary closing conditions, including regulatory approvals.

Why this matters. As the PR mentions, this builds on deep Novartis expertise in IgE biology and a long-standing presence in allergic disease, primarily via Xolair (omalizumab). However, one could also position this acquisition has a portfolio gap-filling exercise since Novartis was developing ligelizumab (formerly QGE031), another anti-IgE asset. Due to ligelizumab not demonstrating superiority vs Xolair in the Phase III PEARL 1 and PEARL 2 trials, development was terminated (ligelizumab no longer appears on the Novartis pipeline). Another recent IgE focused deal is GSK’s $2.2 billion acquisition of RAPT Therapeutics in January 2026, which included ozureprubart, a long-acting anti-IgE mAb, currently in Phase IIb clinical development for prophylactic protection against food allergens. Both deals focused on a desire to gain access to a potentially clinically differentiated asset which could improve clinical outcomes and offer more convenient dosing (due to an extended half-life) across a range of indications, including food allergy, CSU, CIndU, allergic asthma and other IgE-mediated diseases.

Otsuka to acquire Transcend Therapeutics for $1.2 billion

What happened. Otsuka and Transcend Therapeutics have announced that the two companies entered into an agreement where Otsuka will fully acquire Transcend. Under the terms of the agreement, Otsuka will pay $700 million to Transcend shareholders upon closing of the acquisition, and up to $525 million in additional contingent consideration based on future sales milestones related to assets in development, for a total potential consideration of USD $1,225 billion. Transcends lead asset is TSND-201 (methylone), a rapid-acting gent that induces rapid and durable neural plasticity in the brain (i.e., a neuroplastogen). TSND-201 is being developed as a potential treatment for post-traumatic stress disorder (PTSD) and other psychiatric conditions. TSND‑201 demonstrated favorable results in the Phase II IMPACT-1 trial, which enrolled adults with PTSD, and study findings were published in JAMA Psychiatry in February 2026. Due to its rapid onset of activity and robust effects, TSND‑201 was granted Breakthrough Therapy designation by the FDA in July 2025. 

Why this matters. Otsuka's acquisition of Transcend Therapeutics brings a potentially significant new asset into its psychiatric portfolio: TSND-201 (methylone), a non-hallucinogenic neuroplastogen. This fills a genuine pipeline gap in PTSD, where only two approved medications exist (paroxetine and sertraline) and no new treatments have reached patients in roughly 25 years. For competitors, the deal raises the competitive stakes in a space where MDMA-assisted therapies have stumbled. In August 2024, Lykos Therapeutics’ MDMA was rejected by the FDA over trial design concerns. TSND-201's non-hallucinogenic profile and conventional oral dosing may give it a regulatory and commercial advantage over psychedelic-adjacent approaches that require supervised administration settings. For patients, particularly the estimated 13 million Americans living with PTSD, this could represent a meaningful step forward. However, the programme remains investigational, and Phase III data are still pending. On balance, this is a credible strategic move into a high-unmet-need space at a point when the competitive field has thinned following Lykos' setback.

Tempus partners with Daiichi Sankyo on AI-driven R&D

What happened. Tempus AI has announced a strategic collaboration with Daiichi Sankyo aimed at accelerating the clinical development and differentiation of an antibody drug conjugate (ADC) program in oncology. Through this collaboration, Daiichi Sankyo will leverage Tempus’ proprietary foundation models and AI expertise, including PRISM2, a state-of-the-art, multimodal foundation model that combines pathology images and clinical data to generate rich diagnostic and predictive insights. By combining clinical trial and preclinical research data from Daiichi Sankyo with Tempus’ comprehensive real-world data, the collaboration aims to unlock new opportunities for biomarker discovery and patient stratification. Tempus and Daiichi Sankyo will develop proof-of-concept AI models to optimise patient selection and increase probability of success for a novel ADC. By deploying these models across Tempus’ expansive oncology database, the collaboration will generate detailed response maps which will enable precise patient stratification and supporting rigorous benchmarking of potential control arms for future clinical trials.

Why this matters. This deal further validates Tempus’ PRISM2 multimodal AI platform, which combines pathology imaging with clinical data to support biomarker discovery and patient stratification. Daiichi Sankyo currently has two approved ADCs and seven in clinical development, making it one of the most active players in the ADC space. Applying AI-driven biomarker analysis to identify which patients are most likely to respond could improve trial efficiency and sharpen the clinical differentiation story for whichever ADC programme is involved. For competitors in AI-enabled drug development (such as Recursion or Relay Therapeutics) and the ADC field (Pfizer, AbbVie, AstraZeneca), this signals that real-world data platforms are becoming standard tools for clinical trial design, not optional extras. The key caveat is that the press release does not name the specific ADC programme, making it difficult to assess the scale or urgency of the work. Financial terms are also undisclosed. The proof-of-concept framing indicates this remains early-stage. On balance, this is a modest but telling step in the direction of AI-assisted trial design becoming a competitive differentiator in oncology drug development.

In Brief

Biogen’s high dose Spinraza gets FDA nod

FDA approval of a higher dose Spinraza regimen strengthens Biogen’s position in SMA, offering faster loading and potentially improved efficacy, both of which are key for defending share against gene therapy and oral competitors.

Ebglyss shows durable efficacy in eczema

Lilly/Almirall’s lebrikizumab delivers up to four years of sustained control, reinforcing its competitiveness in the crowded atopic dermatitis market where durability and dosing convenience matter.

Eisai/Nuvation Bio’s taletrectinib MAA validated by EMA

Eisai/Nuvation advance their ROS1+ NSCLC therapy into European review, signalling continued global expansion. This follows Eisai and Nuvation Bio announcing in January 2026 they had entered into an exclusive licensing and collaboration agreement in Europe and additional countries outside the US, China and Japan to extend the global reach of taletrectinib

Eli Lilly pushes UK on pricing in exchange for investment

After high-profile moves by a number of big pharma companies to pause their UK investments last year (link, link, link), Eli Lilly is leveraging resumed investment as a bargaining tool, seeking higher NHS drug prices and removal of rebate mechanisms, highlighting mounting tension between pharma and UK market access frameworks.

EMA softens biosimilar development requirements

New guidance from the EMA suggests comparative efficacy studies may no longer be required in some cases, reflecting confidence in analytical methods and potentially lowering biosimilar development costs and timelines.

GSK’s Exdensur (depemokimab) approved in China

GSK’s ultra-long-acting anti-IL-5 therapy (twice-yearly dosing) has been approved in China as add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients aged 12 years and older, strengthening GSK’s respiratory portfolio and reinforcing differentiation via convenience in severe asthma. The approval of Exdensur in severe asthma is based on data from the Phase III SWIFT-1 and SWIFT-2 trials.

Kardigan’s tonlamarsen shows promise in hypertension

Kardigan has announced results from the Phase II KARDINAL trial evaluating the effects of tonlamarsen in patients with uncontrolled hypertension. Phase II data for tonlamarsen show meaningful BP reduction via AGT targeting, supporting progression into later-stage trials and positioning in resistant hypertension.

Kodiak’s Zenkuda succeeds in Phase III

Kodiak Sciences has announced positive topline results from the Phase III GLOW2 superiority study of Zenkuda (tarcocimab tedromer) for the treatment of patients with diabetic retinopathy. These positive results confirm efficacy in broader populations, reinforcing its potential in anti-VEGF space with differentiated delivery technology.

Neion Bio enters biosimilar manufacturing

Neion Bio has announced the signing of its first co-development and supply agreement with a major global pharmaceutical company. Neion’s Raptor platform utilises the latest genetic engineering tools to produce recombinant biologics in eggs, enabling scalable and efficient production of virtually any therapeutic protein. This novel egg-based platform offers low-cost, scalable biologics production, and this early partnership provides validation of a differentiated manufacturing model.

CVC bids €10.9 billion for Recordati

Luxembourg-based CVC has offered €10.9 billion for Italy’s Recordati. The investment firm, which already has a 47% stake in Recordati that it acquired in June 2018, intends to delist it, the Italian pharma said in its statement. Recall, Recordati acquired EUSA Pharma for €750 million in March 2022. The deal brought Cushing disease drug Isturisa (osilodrostat).

Rocket secures gene therapy approval plus PRV upside

Rocket Pharmaceuticals has announced that the FDA has granted accelerated approval for Kresladi (marnetegragene autotemcel), an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of paediatric patients with severe leukocyte adhesion deficiency-I (LAD-I). With the approval of KRESLADI, the FDA granted Rocket a Rare Paediatric Disease Priority Review Voucher (PRV), a program designed to encourage development of therapies for rare paediatric diseases. This not only validates the platform but also creates near-term financial optionality via PRV monetisation.

Simulations Plus expands AI collaborations

Simulations Plus has announced strategic collaboration programmes with three large pharmaceutical companies to advance artificial intelligence (AI) workflows across the drug development lifecycle. These partnerships with aim to embed AI into real-world R&D workflows, signalling gradual but practical integration of AI across drug development. The programs will utilize Simulations Plus’ major software platforms, including GastroPlus, MonolixSuite, ADMET Predictor, and Thales.

UCB’s Kygevvi approved in Europe

Following a positive endorsement from the EMA’s CHMP in January 2026, UCB has received EC approval for Kygevvi (doxecitine and doxribtimine), the first and only authorised treatment for thymidine kinase 2 deficiency, an ultra‑rare and life‑threatening mitochondrial condition marked by progressive muscle weakness. The decision covers paediatric and adult patients with genetically confirmed TK2d whose symptoms began at or before age 12.

Viridian’s elegrobart succeeds in Phase III

Viridian Therapeutics has announced positive topline data from the Phase III REVEAL-1 trial in patients with active thyroid eye disease (TED) who were treated with elegrobart, a subQ, half-life-extended anti-IGF-1R mAb. These positive results in thyroid eye disease position elegrobart as a potential competitor in the IGF-1R class, with differentiated dosing options vs. treatments like Amgen’s Tepezza (teprotumumab).

About the Author

Duncan Emerton is a pharmaceutical industry professional with a background spanning clinical research and development, medical affairs, and strategic consulting. He brings a commercially minded perspective to complex scientific and market developments, with experience in competitive intelligence, business analysis, and portfolio strategy across the life sciences sector. Through Pharma Phriday, Duncan provides concise, insight-driven commentary on the stories shaping the pharmaceutical and biotech landscape, helping readers filter out the noise to understand what really matters for companies, competitors, and patients alike.